Lipoaspirate processing

ABSTRACT

Disclosed are methods and devices for processing lipoaspirate that include mechanically-processing harvested lipoaspirate in a liposuction filter canister. In some embodiments, the devices are liposuction devices that include a lipoaspirate processing unit for mechanically-processing lipoaspirate. The mechanical processing reduces the average size of adipose tissue pieces in the lipoaspirate without substantially rupturing lipocytes therein.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims is a continuation of U.S. Pat. ApplicationSerial No. 17/549,127, filed on Dec. 31, 2021, which is a continuationof U.S. International Patent Application No. PCT/IB2021/051910, filed onMar. 8, 2021, which claims priority to and the benefit of British PatentApplication No. GB 2008023.0, filed May 28, 2020, and U.S. ProvisionalApplication No. 62/986,806, filed on Mar. 9, 2020, the entire disclosureof which are hereby incorporated by reference and relied upon.

TECHNICAL FIELD

The invention, in some embodiments, relates to the fields of aestheticsand/or medicine and, more particularly but not exclusively, to methodsand devices for processing lipoaspirate.

BACKGROUND OF THE INVENTION

Liposuction is a well-known method for aesthetic body-shaping whereportions of subcutaneous adipose tissue are harvested from a part of thebody of a subject as a lipoaspirate by suction through a cannula.Typically, suction is accompanied by simultaneous irrigation with anaqueous tumescent solution.

The harvested lipoaspirate comprises adipose tissue together with fluidwaste including blood and tumescent solution.

Autologous Fat Transfer (AFT)

Often, harvested lipoaspirate is used for autologous fat transfer (AFT).For AFT, the fluid waste is removed from the harvested lipoaspirate andthe remaining lipoaspirate washed one or more times with an aqueouswashing solution, leaving a clean lipoaspirate consisting essentially ofpieces of adipose tissue. The clean lipoaspirate is injected into aportion of the body, in some instances as-is and, in other instances,subsequent to a homogenization step performed by transferring the cleanlipoaspirate back-and-forth between two coupled syringes to reduce thesize of the adipose tissue pieces.

Stromal Vascular Fraction (SVF)

It has become accepted to process at least some harvested lipoaspirateto produce a stromal vascular fraction (SVF), which includesadipose-derived stromal cells (ASCs) useful for various purposesincluding: regenerative medicine, wound healing (e.g., post-radiotherapywound-healing), treating osteoarthritis and treating autoimmune disease(e.g., scleroderma, lichen sclerosis). To this end, an amount oflipoaspirate (usually clean lipoaspirate) is processed (enzymaticallyand/or mechanically) to disintegrate the adipose tissue and release ASCsand the like that are in the tissue. The disintegrated adipose tissue iscentrifuged to separate the lighter fatty remnants from the intact ASCswhich settle at the bottom of the centrifuge vessel as an SVF pellet.The SVF pellet is suspended in an aqueous solution to separate ASCs fromcontaminants and again centrifuged, thereby providing a purified SVFpellet. The purified SVF pellet can be suspended in an aqueous solutionand used therapeutically as-is. Preferably, the purified SVF pellet iscultured in a medium that keeps the ASCs viable while eliminatingnon-ASCs. After a sufficient culturing time (typically a few days), thethus-purified ASCs can be used therapeutically.

Enriched Lipoaspirate for Improved AFT

One of the challenges of AFT as described above is resorption of asubstantial portion of the transplanted adipose tissue. Such resorptioncan lead to poor aesthetic results and often requires that an AFTprocedure be repeated multiple times to achieve a desired aestheticeffect.

It has been found that it possible to perform improved AFT by using alipoaspirate that is enriched by the addition of an SVF or ASCs prior toinjection into the body. When the enriched lipoaspirate is transferredto the body in the usual way, there is reduced resorption and increasedtransplanted fat retention.

In a typical improved AFT procedure, a relatively large quantity oflipoaspirate is harvested by liposuction for body-shaping (-1000 ml). Asmall amount (typically ~100 ml) of the harvested lipoaspirate isprocessed to yield an SVF pellet, typically -1% w/w of the processedlipoaspirate. The SVF, or ASCs isolated therefrom, is added to an amountof unprocessed clean lipoaspirate (typically 100 ml, optionallyhomogenized as described above) to provide enriched lipoaspirate whichis then used for improved AFT. As a result of the enrichment, improvedAFT is more successful and provides better results than AFT usingnon-enriched lipoaspirate.

It would be useful to find a simple manner to process a lipoaspiratethat can be used for AFT which has one or more advantages over knownmethods of lipoaspirate processing.

BRIEF SUMMARY OF THE INVENTION

Some embodiments of the invention herein relate to methods and devicesfor processing lipoaspirates, in some embodiments to be suitable for AFTand in some embodiments to make an SVF.

According to an aspect of some embodiments of the invention, there isprovided a method of processing lipoaspirate, comprising:

-   a. receiving a lipoaspirate harvested from a subject in a    liposuction filter canister;-   b. subsequent to ‘a’, mechanically processing (in some embodiments,    vortex-mixing) the lipoaspirate inside the liposuction filter    canister to mix the lipoaspirate, the mechanical processing reducing    the average size of adipose tissue pieces in the lipoaspirate    without substantially rupturing lipocytes therein; and-   c. subsequent to ‘b’, draining fluid released from the lipoaspirate    by the mechanical processing from the liposuction filter canister    fluid,

thereby providing processed lipoaspirate contained in the liposuctionfilter canister.

As used herein, “mechanically processing” means that the lipoaspirate iscaused to move relative to the filter liner of the liposuction filtercanister, the motion sufficient to break-up the pieces of adipose tissuein the lipoaspirate so that the average size of the pieces of adiposetissue in the lipoaspirate is reduced. In some embodiments, the averagesize of the adipose tissue pieces is reduced to 50% of the original, to25% of the original and even to 10% of the original.

As used herein, “without substantially rupturing lipocytes therein”means that at least 90%, at least 95% and even at least 98% of thelipocytes in the lipoaspirate are not ruptured as a result of themechanical processing.

In some embodiments, ‘b’ starts only when ‘a’ is complete, that is tosay, all the desired harvested lipoaspirate is received (‘a’) prior tostarting the mechanical processing (‘b’). Alternately, in someembodiments, mechanical processing (‘b’) is started when at least someharvested lipoaspirate is received (‘a’). As a result, in such alternateembodiments mechanical processing is performed concurrently with receiptof some harvested lipoaspirate.

Any suitable manner of mechanical processing that reduces the averagesize of the pieces of adipose tissue but is gentle enough to avoidsubstantial rupturing of lipocytes may be used in implementing theteachings herein. In some embodiments, the mechanical processing isselected from the group consisting of: vortex mixing the lipoaspirate inthe canister; vibrating the lipoaspirate in the canister; andmechanically-mixing the lipoaspirate in the canister. Especiallypreferred is vortex-mixing that has been experimentally shown to providehigh-quality processed lipoaspirate, is currently believed to moreeasily be kept aseptic and is easy to implement.

Thus, according to an aspect of some embodiments of the invention, thereis also provided a method of processing lipoaspirate, comprising:

-   a. receiving a lipoaspirate harvested from a subject in a    liposuction filter canister;-   b. subsequent to ‘a’, vortex-mixing the lipoaspirate inside the    liposuction filter canister to mix the lipoaspirate; and-   c. subsequent to ‘b’, draining fluid released from the lipoaspirate    by the vortex-mixing from the liposuction filter canister,

thereby providing processed lipoaspirate contained in the liposuctionfilter canister.

Thus, according to an aspect of some embodiments of the invention, thereis also provided a method of processing lipoaspirate, comprising:

-   a. receiving a lipoaspirate harvested from a subject in a    liposuction filter canister;-   b. subsequent to ‘a’, mechanically-mixing the lipoaspirate inside    the liposuction filter canister to mix the lipoaspirate; and-   c. subsequent to ‘b’, draining fluid released from the lipoaspirate    by the mechanical mixing from the liposuction filter canister,

thereby providing processed lipoaspirate contained in the liposuctionfilter canister.

In some embodiments, the mechanical processing, such as vortex mixing,is applied within 60 minutes of harvesting of the lipoaspirate.

In some embodiments, prior to and/or during the mechanical processing,e.g. vortex mixing, a volume of aqueous solution is added to theliposuction filter canister.

In some embodiments, the mechanical processing is vortex mixing that isperformed at not more than 3000 rpm and even not more than 1000 rpm.

In some embodiments, the mechanical processing is vortex mixing that isperformed for not more than 30 minutes.

In some embodiments, the mechanical processing is vortex mixing that isperformed for not less than 60 seconds.

In some embodiments, the liposuction filter canister is in a state ofbeing functionally-associated with a fluid drainage module during themechanical processing, that is to say, that to perform mechanicalprocessing there is no need to disconnect an already-connected fluiddrainage module.

In some embodiments, the fluid drainage module is a component of aliposuction vacuum module.

In some embodiments, the method of processing lipoaspirate furthercomprises: subsequent to the draining ‘c’, transferring the lipoaspirateto an autologous fat transfer (AFT) device. In some embodiments, themethod of processing lipoaspirate further comprises transplanting thetransferred lipoaspirate to a subject using the AFT device.Alternatively, in some embodiments, a step of transplanting thetransferred lipoaspirate is a method of surgical treatment and isoutside the scope of the claims.

In some embodiments, the lipoaspirate in the liposuction filter canisteris not washed subsequent to the mechanical processing, such as vortexmixing, ‘b’ and prior to the transferring of the lipoaspirate to an AFTdevice.

In some embodiments, the lipoaspirate in the liposuction filter canisteris not centrifuged subsequent to the mechanical processing, such asvortex mixing, ‘b’ and prior to the transferring of the lipoaspirate toan AFT device.

In some embodiments, the liposuction canister filter has a volume of notless than 50 ml and not more than 10,000 ml.

In some embodiments, an amount of the harvested lipoaspirate received inthe liposuction filter canister is not less than 50 ml and not more than10,000 ml.

In some embodiments, the lipoaspirate was harvested from a subject usinga method selected from the group consisting of laser-assistedliposuction, ultrasound-assisted liposuction and RF-assistedliposuction.

In some embodiments, the laser-assisted liposuction was performed usinga laser wavelength within the range 800 - 1600 nm, and in someembodiments with the range 1400 -1500 nm.

In some embodiments, the laser-assisted liposuction was performed usinga radially-irradiating optical fiber.

Any suitable cannula having any suitable size may be used inimplementing the teachings herein, in some embodiments, the lipoaspiratewas harvested using a cannula with an internal diameter of at least 2 mmand not more than 5 mm.

Any suitable suction pressure may be used for harvesting thelipoaspirate. In some embodiments, the lipoaspirate was harvested usinga suction pressure of at least 20 kP and not more than 98 kP.

In some embodiments, the method further comprises: d. subsequent to ‘c’,applying additional mechanical processing (such as vortex mixing or anyother option listed above) to the lipoaspirate contained in theliposuction filter canister to mix the lipoaspirate, the additionalmechanical processing reducing the average size of adipose tissue piecesin the lipoaspirate without substantially rupturing lipocytes therein.

In some embodiments, the method further comprises: subsequent to theadditional mechanical processing ‘d’, transferring the lipoaspirate toan autologous fat transfer (AFT) device. In some embodiments, the methodfurther comprises transplanting the transferred lipoaspirate to asubject using the AFT device. Alternatively, in some embodiments, a stepof transplanting the transferred lipoaspirate is a method of surgicaltreatment and is outside the scope of the claims. In some embodiments,the method further comprises: e. subsequent to ‘d’, isolating fluidreleased from the lipoaspirate consequent to the additional mechanicalprocessing as an SVF fluid.

Embodiments of the method may be implemented using any suitable deviceor combination of devices. In some preferred embodiments, the method isimplemented using a liposuction device according to the teachingsherein.

According to an aspect of some embodiments of the invention, there isalso provided a liposuction device that, in some embodiments, isexceptionally suitable for implementing embodiments of the methodaccording to the teachings herein.

Thus, according to an aspect of some embodiments of the invention, thereis also provided a liposuction device configured for performingliposuction by drawing adipose tissue from a body as a lipoaspiratethrough a cannula and transferring (also termed “transporting” in thepriority document) at least some the harvested adipose tissue into aliposuction filter canister functionally associated with the liposuctiondevice, the device comprising: a lipoaspirate processing unit,

the lipoaspirate processing unit configured, when activated, tomechanically process lipoaspirate contained inside a liposuction filtercanister functionally-associated with the liposuction device, themechanically processing reducing the average size of adipose tissuepieces in the lipoaspirate without substantially rupturing lipocytestherein. Without wishing to be held to any one theory, it is currentlybelieved that such gentle mechanical processing produces a relativelyhomogenous processed lipoaspirate that includes various non-factors(e.g., SVF) in a form that is accessible for use when transplanted.

In some embodiments, the liposuction device further comprises: aliposuction vacuum module attachable to a liposuction filter canisterwhich is functionally-associated with the liposuction device through avacuum port thereof, the liposuction vacuum module configured, whenattached to a liposuction filter canister and activated, to effectliposuction through the liposuction filter canister and through aliposuction probe functionally associated therewith, thereby allowingtrapping of harvested adipose tissue (i.e., adipose tissue that isharvested as a consequence of the liposuction) in a filter liner of theattached filter canister. In some embodiments, the liposuction device isconfigured to allow activation of the lipoaspirate processing unit tomechanically process the contents of a liposuction filter canisterfunctionally associated with the liposuction device while theliposuction filter canister is attached to the liposuction vacuummodule.

In some embodiments, the liposuction device comprises a fluid drainagemodule different from the liposuction vacuum module, the fluid drainagemodule attachable to a liposuction filter canister that isfunctionally-associated with the liposuction device through a drainageport thereof, the fluid drainage module configured, when attached tosuch a liposuction filter canister and activated, to remove liquids froma container of the attached liposuction filter canister. In someembodiments, the liposuction device is configured to allow activation ofthe lipoaspirate processing unit to mechanically process the contents ofa liposuction filter canister functionally associated with theliposuction device while the liposuction filter canister is attached tosaid fluid drainage module.

In some embodiments, the liposuction device further comprises aliposuction probe having a distal end attachable to a liposuctioncannula and a proximal end attachable to a liposuction filter canisterthat is functionally-associated with the liposuction device through anaspirate inlet thereof, the liposuction probe configured to directliposuction aspirate harvested via an attached liposuction cannula fromthe distal end of the probe through the proximal end of the probe into acontainer of an attached liposuction filter canister. In someembodiments, the liposuction device is configured to allow activation ofthe lipoaspirate processing unit to mechanically process the contents ofa liposuction filter canister that is functionally associated with theliposuction device while the liposuction filter canister is attached tothe liposuction probe.

In some embodiments, the liposuction device further comprises a washingmodule attachable to a liposuction filter canisterfunctionally-associated with the liposuction device through an accessport thereof, the washing module configured to add an amount of liquid(e.g., washing solution) into a container of an attached liposuctionfilter canister, preferably a metered amount of liquid. In someembodiments, the liposuction device is configured to allow activation ofthe lipoaspirate processing unit to mechanically process the contents ofa liposuction filter canister functionally-associated with theliposuction device while the liposuction filter canister is attached tothe washing module.

In some embodiments, the liposuction device further comprises acontroller configured to automatically process lipoaspirate contained ina liposuction filter canister that is functionally associated with theliposuction device, the automatic processing comprising activation ofthe lipoaspirate processing unit, the fluid drainage module and/or thewashing module in a desired order for a desired duration. In someembodiments, the controller is configured to activate only one of thethree units/modules. In some embodiments, the controller is configuredto activate only two of the three units/modules. In some embodiments,the controller is configured to activate all three units/modules.

In some embodiments, the liposuction device further comprises aliposuction filter canister functionally-associated with the liposuctiondevice, the liposuction filter canister including: a container; alongitudinal axis, a canister vacuum port (preferably attached to theliposuction vacuum module); a cap for sealingly closing the container; acanister aspirate inlet (preferably attached to a proximal end of theliposuction probe; an access port (preferably attached to the washingmodule); and a filter liner that defines an inner volume inside thecontainer, the filter canister configured so that when attached to theliposuction probe through the canister aspirate inlet and attached tothe liposuction vacuum module through the vacuum port, activation of theliposuction vacuum module allows effecting liposuction through theliposuction probe and trapping of harvested adipose tissue in the filterliner (i.e., in the inner volume defined by the filter liner). In someembodiments, the liposuction filter canister further comprises adrainage port attachable to (and preferably attached to) the liquiddrainage module, the drainage port allowing the removal of liquid heldin the container outside of the filter liner. In some embodiments, thedrainage port is the canister vacuum port. Alternately, in someembodiments, the drainage port is a component different from thecanister vacuum port. The filter canister is any suitable size, e.g., asrecited below.

Vortex Mixing Unit

In some preferred embodiments, the lipoaspirate processing unitcomprises a vortex mixing unit, the vortex-mixing unit configured, whenactivated, to produce and apply vortex-inducing motion to a liposuctionfilter canister functionally-associated with the liposuction device, thevortex-inducing motion effective to mechanically process lipoaspiratecontained in the inner volume of the filter canister.

In some embodiments, the vortex-mixing unit includes an engagementcomponent that transfers at least some vortex-inducing motion producedby the vortex-mixing unit to a liposuction filter canisterfunctionally-associated with the liposuction device when thevortex-mixing unit is activated.

In some embodiments, the vortex-mixing unit is configured so that abottom of a filter canister functionally-associated with the liposuctiondevice rests on the vortex-mixing unit. Such an embodiment is depictedin FIGS. 2A, 2B and 2C.

In some such embodiments, the vortex-mixing unit includes a flat uppersurface on which a flat bottom of a filter canisterfunctionally-associated with the liposuction device rests. Such anembodiments is depicted in FIGS. 2A and 2B. In some such embodiments,the flat upper surface is defined by an upper surface of an engagementcomponent of the vortex-mixing unit. Such an embodiment is depicted inFIG. 2A.

In some such embodiments, the engagement component at least partiallyencircles a bottom of filter canister resting on the flat upper surface.Such an embodiment is depicted in FIG. 2B.

In some such embodiments, the vortex-mixing unit includes a non-flatupper surface on which the non-flat bottom of a liposuction filtercanister functionally-associated with the liposuction device rests, thenon-flat upper surface encircling at least part of a bottom portion of afilter canister. Such an embodiment is depicted in FIG. 2C.

In some embodiments, the vortex-mixing unit is configured, whenactivated, to vortex-mix the contents of a liposuction filter canisterfunctionally-associated with the liposuction device at not more than3000 rpm, not more than 2000 rpm, not more than 1000 rpm, and in someembodiments even not more than 700 rpm. In some embodiments, thevortex-mixing unit is configured, when activated, to vortex-mix thecontents of a liposuction filter canister functionally-associated withthe liposuction device at not less than 60 rpm, and in some embodimentseven not less than 100 rpm.

In some embodiments, the vortex-mixing unit and/or a controller of theliposuction device are configured to allow vortex-mixing of the contentsof a liposuction filter canister functionally-associated with theliposuction device for a period of not more than 30 minutes, not morethan 20 minutes, not more than 10 minutes and even not more than 7minutes.

In some embodiments, the vortex-mixing unit and/or the controller areconfigured to allow vortex-mixing of the contents of a liposuctionfilter canister functionally-associated with the liposuction device fora period of not less than 30 seconds and even not less than 60 seconds.

Vibration Unit

In some embodiments, the lipoaspirate processing unit comprises avibration unit, the vibration unit configured, when activated, toproduce and apply vibrations to lipoaspirate contained in the innervolume of a liposuction filter canister functionally-associated with theliposuction device, the vibrations effective to mechanically process thelipoaspirate.

In some embodiments, the vibration unit comprises at least one sonictransmitter probe configured to be positioned inside an inner volumedefined by the filter liner of a liposuction filter canisterfunctionally-associated with the liposuction device. In suchembodiments, during use the probe is at least partially immersed in thelipoaspirate. Such an embodiment is depicted in FIGS. 3A and 3B.

In some embodiments, the vibration unit comprises a sonic transmitterconfigured to physically-associate with a filter liner of a liposuctionfilter canister functionally-associated with the liposuction device sothat when activated, said sonic transmitter causes aphysically-associated filter liner to vibrate. The vibrating filterliner transfers the vibrations from the sonic transmitter to thelipoaspirate held therein. Such an embodiment is depicted in FIG. 3C.

It is important to note that, in some such embodiments, the sonictransmitter is a component of a liposuction filter canister and theliposuction device is configured, for example includes electricalconnectors, to allow operation of the sonic transmitter of theliposuction canister in accordance with the teachings herein.

Mechanical Mixing

In some embodiments, the lipoaspirate processing unit comprises:

-   a mechanical mixing component configured to be positioned inside an    inner volume defined by a filter liner of a liposuction filter    canister functionally-associated with the liposuction device; and-   a mixing motor configured to move the mechanical mixing component    relative to lipoaspirate contained in the volume to thereby    mechanically-mix the lipoaspirate, the mechanical mixing effective    to mechanically process the lipoaspirate.

In some embodiments, the mixing motor is configured so that the relativemotion of the mechanical mixing component to the liposuction filtercanister comprises, or is, translation in parallel to the longitudinalaxis of the liposuction filter canister. Such an embodiment is depictedin FIGS. 4A-1, 4A-2, 4A-3, 4A-4, 4B and 4C. In some such embodiments,the filter canister is moved in parallel to the longitudinal axis (FIG.4B). Additionally, or alternatively, in some such embodiments, themechanical mixing component is moved in parallel to the longitudinalaxis (FIG. 4C). In some such embodiments, the mechanical mixingcomponent comprises, or is, a flow-restricting barrier such as apervious plunger (FIGS. 4A-1, 4A-2, 4A-3 and 4A-4 ). In some suchembodiments, the mechanical mixing component, such as a flow-restrictingbarrier, is a component of the filter canister. In some suchembodiments, the mechanical mixing component, such as a flow-restrictingbarrier, is not a component of the filter canister.

Alternately or additionally, in some embodiments, the mixing motor isconfigured to rotate the filter liner relative to a container of theliposuction filter canister around an axis parallel to the longitudinalaxis of the liposuction canister. Such an embodiment is depicted inFIGS. 4D and 4E. In some such embodiments, the mechanical mixingcomponent comprises mixing elements affixed to an inner surface of thefilter liner and protruding into the inner volume that rotate togetherwith the filter liner (FIGS. 4D and 4E). Additionally, or alternately,in some embodiments the mechanical mixing component comprises mixingelements that do not rotate together with the filter liner (FIG. 4E).

Alternately or additionally, in some embodiments the mixing motor isconfigured to rotate a mechanical mixing component that is separate fromthe filter liner located inside inner volume. Such an embodiment isdepicted in FIGS. 4F, 4G and 4H. Any suitable type, or combination oftypes, of mechanical mixing component, e.g., one or more componentsselected from the group consisting of an impeller (FIG. 4F), a propellor(FIG. 4G) and a paddle (FIG. 4H). In some such embodiments, themechanical mixing component is a component of the filter canister. Insome such embodiments, the mechanical mixing component is not acomponent of the filter canister.

In some embodiments, the liposuction device is selected from the groupconsisting of: a laser-assisted liposuction device; anultrasound-assisted liposuction device; and an RF-assisted liposuctiondevice.

In some embodiments, the liposuction device is a laser-assistedliposuction device, configured to irradiate adipose tissue with laserlight having a wavelength within the range 800 nm and 1600 nm duringliposuction. In some embodiments, the laser wavelength is within therange of 1400 nm - 1500 nm, 1450 - 1490 nm and even within the range of1460 - 1480 nm, for example a laser wavelength of 1470 nm as is used insome commercially-available laser-assisted liposuction devices.

In some embodiments, the liposuction device is a laser-assistedliposuction device, configured to perform liposuction using aradially-irradiating optical fiber.

In some embodiments, the liposuction device is configured to harvestlipoaspirate through a cannula with an internal diameter of at least 2mm and not more than 5 mm.

In some embodiments, the liposuction device is configured to apply asuction pressure of at least 20 kP and not more than 98 kP.

Liposuction filter canisters of the teachings herein

In some embodiments, the teachings herein are implemented using aliposuction filter canister according to the teachings herein.

According to an aspect of some embodiments of the teachings herein,there is provided a liposuction filter canisterfunctionally-associatable with a liposuction device, comprising: acontainer having a longitudinal axis; a canister vacuum portfunctionally-associatable with a liposuction vacuum module of aliposuction device; a cap for sealingly closing the container; acanister aspirate inlet attachable to a proximal end of a liposuctionprobe; and a filter liner that defines an inner volume inside thecontainer, the filter canister configured so that when attached to aliposuction probe through the canister aspirate inlet and attached to aliposuction vacuum module through the vacuum port, activation of theattached liposuction vacuum module allows effecting liposuction throughthe liposuction probe and trapping of harvested adipose tissue in theinner volume defined by the filter liner, the liposuction filtercanister further comprising at least one of:

-   i. a sonic transmitter probe located inside the inner volume, the    probe configured to vibrate at an acoustic frequency of not more    than 10 kHz when activated (so that such activation leads to    mechanical processing of lipoaspirate held in the inner volume);-   ii. a sheath protruding into the inner volume, the sheath configured    for accepting a sonic transmitter probe (so that when the probe is    activated to vibrate, the vibrations pass through the sheath,    leading to mechanical processing of lipoaspirate held in the inner    volume);-   iii. a sonic transmitter physically-associated with the filter    liner, the sonic transmitter configured to cause the filter liner to    vibrate at an acoustic frequency of not more than 10 kHz when    activated (so that such activation leads to mechanical processing of    lipoaspirate held in the inner volume); and-   iv. a mechanical mixing component located inside the inner volume,    the mechanical mixing component configured to be functionally    associated with a mixing motor and, when the mixing motor is    activated, to move relative to lipoaspirate contained in the inner    volume (so that such relative motion leads to mechanical processing    of lipoaspirate held in the volume).

In some embodiments, the mechanical mixing component is configured tomove with a motion vector that is, or includes, a component parallel tothe longitudinal axis. (e.g., the mechanical mixing component is, orcomprises, a flow-restricting barrier such as a partially-perviousplunger).

In some embodiments, the mechanical mixing component is configured torotate relative to the container (e.g., the mechanical mixing componentcomprises or is a propellor, an impeller or a paddle; or the filterliner is configured to rotate).

BRIEF DESCRIPTION OF THE DRAWINGS

Some embodiments of the invention are described herein with reference tothe accompanying figures. The description, together with the figures,makes apparent to a person having ordinary skill in the art how someembodiments of the invention may be practiced. The figures are for thepurpose of illustrative discussion and no attempt is made to showstructural details of an embodiment in more detail than is necessary fora fundamental understanding of the invention. For the sake of clarity,some objects depicted in the figures are not to scale. In the Figures:

FIG. 1 is a schematic depiction of an embodiment of a liposuction filtercanister useful for implementing the teachings herein;

FIGS. 2A - 2D are schematic depictions of embodiments of devices usefulfor implementing embodiments of the methods according to the teachingsherein, the devices including a laser-assisted liposuction unit and avortex-mixing unit;

FIGS. 3A - 3C are schematic depictions of components of embodiments ofdevices useful for implementing embodiments of the methods according tothe teachings herein, the devices including a vibration unit; and

FIGS. 4A-1, 4A-2, 4A-3, 4A-4 and 4B to 4H are schematic depictions ofcomponents of embodiments of devices useful for implementing embodimentsof the methods according to the teachings herein, the devices configuredfor mechanical mixing.

DETAILED DESCRIPTION

Some embodiments of the invention herein relate to methods and devicesfor processing lipoaspirate, in some embodiments to be suitable for AFT(autologous fat transfer) and in some embodiments to make an SVF(stromal vascular factor).

The principles, uses and implementations of the teachings of theinvention may be better understood with reference to the accompanyingdescription and figures. Upon perusal of the description and figurespresent herein, one skilled in the art is able to implement theteachings of the invention without undue effort or experimentation. Inthe figures, like reference numerals refer to like parts throughout.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not necessarily limited in itsapplication to the details of construction and the arrangement of thecomponents and/or methods set forth herein. The invention is capable ofother embodiments or of being practiced or carried out in various ways.The phraseology and terminology employed herein are for descriptivepurpose and should not be regarded as limiting.

As is known in the art, tissue, including the adipose tissue that makesup lipoaspirate, can be mechanically processed in many ways for example,using a meat grinder (US 5,731,199), a perforated rasp (WO 2016/097960),forcing the fat through perforations (WO 2017/180076, WO 2019/125324)and using a high speed rotating blade as a “food processor” (WO2016/199149).

The Inventors, after studying the art and performing experiments,conclude that mechanical processing of lipoaspirate can be considered ashaving a combination of three separate effects.

The first of the three effects is homogenization of the lipoaspirate,reducing the size of the adipose tissue pieces to produce a more fluidlipoaspirate including viable lipocytes that can more easily and moreaccurately be injected during an AFT procedure, providing improvedaesthetic results.

The second of the three effects is damaging the adipose tissue andrupturing lipocytes in the lipoaspirate, leading to the productionand/or release of harmful factors such as pro-inflammatory and toxicmaterials including cell / tissue fragments as well as hormones andother factors. The Inventors believe that such harmful factorscontribute in a large part to the challenges and complications of knownAFT procedures including inflammation and post-transplantationresorption of transplanted fat.

The third of the three effects is the release of beneficial factors fromthe adipose tissue. Beneficial factors include stem cells and the likethat make up the SVF, well known for having therapeutic properties. Asdiscussed in the introduction, subsequent to mechanical or enzymaticprocessing, the beneficial factors can be isolated for therapeutic useas-is or for implementing improved AFT.

In the art, the three effects are considered in isolation, each for aspecific use:

For AFT, modest homogenization of lipoaspirate is performed to produce amore fluid lipoaspirate that can be more accurately transferred to asubject using a smaller needle during AFT. Additionally, whether or nothomogenized, lipoaspirates that are used for AFT are rigorously andrepeatedly washed with a washing solution to remove harmful factors.

When it desired to provide SVF or isolated ASCs from a harvestedlipoaspirate, the lipoaspirate is vigorously processed to completelydestroy the adipose tissue and lipocytes to ensure that the maximalamount of ASCs are released from the tissue, followed by extensivepurification (including centrifugation, washing with a washing solutionand culturing) to remove harmful factors and producetherapeutically-useful SVF or ASCs. As discussed above, one use of suchpurified SVF / ASCs is to enrich lipoaspirate for improved AFT.

The Inventors have discovered and now disclose a method for processinglipoaspirate which balances these three effects, yielding a lipoaspiratethat is apparently enriched. Specifically, the Inventors have discoveredthat it is possible to gently mechanically process a harvestedlipoaspirate to produce a lipoaspirate that is apparently enriched withbeneficial factors yet has few, if any, harmful factors. In someembodiments, the methods yields a processed lipoaspirate that increasesthe success of AFT performed using the processed lipoaspirate, forexample by one or both of reducing the amount of post-AFT inflammationand reducing resorption of transplanted fat. The method is exceptionallysuitable for use with lipoaspirate harvested using gentle liposuctionmethods such as laser-assisted liposuction. Further, the Inventors havefound that some embodiments of the method allow for aseptic preparationof AFT in a clinical setting with little human intervention.

In some embodiments, the method is quicker than some known methods,allowing for lipoaspirate harvesting, processing and subsequent improvedAFT in a relatively short time that is suitable for a single-session atan aesthetic or therapeutic clinic. It is believed that in someembodiments a shorter harvest-to-AFT time reduces stress on transferredtissue which can further increase the success of the AFT.

In some embodiments, the method is performed in a way that more easilyprevents contamination, allowing for safer AFT with a reduced chance ofinflammation and even sepsis, increasing customer satisfaction andreducing liability for a clinic that practices the method.

In some embodiments, the method is easy to perform, even for a personwho is pressed for time or not an expert laboratory technician, forexample a nurse or an assistant in a clinic that practices the method.

In some embodiments, the method is easy to at least partially automate,reducing the workload required from personnel and in some embodimentsimproving repeatability and consistency of the results, even whenperformed by a person who is not an expert laboratory technician.

Method for Processing Lipoaspirate

According to an aspect of some embodiments of the teachings herein,there is provided a method of processing lipoaspirate, comprising:

-   a. receiving a lipoaspirate harvested from a subject contained in a    liposuction filter canister;-   b. subsequent to ‘a’, mechanically processing (in some embodiments,    vortex-mixing) the lipoaspirate inside the liposuction filter    canister to mix the lipoaspirate, the mechanical processing reducing    the average size of adipose tissue pieces in the lipoaspirate    without substantially rupturing lipocytes therein; and-   c. subsequent to ‘b’, draining fluid released from the lipoaspirate    by the mechanical processing from the liposuction filter canister    fluid, thereby providing processed lipoaspirate contained in the    liposuction filter canister.

Receiving Lipoaspirate in a Liposuction Filter Canister

In ‘a’, lipoaspirate harvested from a subject is received in aliposuction filter canister. Preferably, the liposuction filter canisteris a single-use sterile liposuction filter canister. Any suitableliposuction filter canister can be used, includingcommercially-available liposuction filter canisters such as the Contour™canisters from Bemis® Health Care™, Sheboygan Falls, WI, USA orTissue-Trans® Filtron Units fromTulip® Medical Instruments, San Diego,CA, USA. In some embodiments, the liposuction filter canister is aliposuction filter canister according to the teachings herein.

An exemplary liposuction filter canister 10 is schematically depicted incross section in FIG. 1 . Liposuction filter canister 10 includes acontainer 12, a longitudinal axis 13, a canister vacuum port 14, and acap 16 that sealingly-closes container 12. Through cap 16 is a canisteraspirate inlet 18 and a sealable access port 20. Held inside container12 is a filter liner 22 (having filter holes, typically between 100micrometers and 1000 micrometers) that defines an inner volume 23.Sealable access port 20 is an opening that can be optionally closed,preventing entry of contamination and air into container 12, but can bereversibly opened, allowing addition of materials (e.g., washingsolution) or removal of materials (e.g., a sample of lipoaspirate heldin filter liner 22).

For use (see FIGS. 2A-2D), canister 10 is functionally-associated with aliposuction device 24 by holding canister 10 in a filter canister holder25, connecting canister vacuum port 14 to a liposuction vacuum module 26of liposuction device 24 and connecting canister aspirate inlet 18 to aliposuction probe 28 at which distal end is found a liposuction cannula30.

Vacuum module 26 is activated, producing suction at the liposuctioninlets of cannula 30. When cannula 30 is contacted with in vivo adiposetissue, adipose tissue in drawn from the body into cannula 30 andtransferred into canister 10 as lipoaspirate. Adipose tissue is trappedin inner volume 23 of filter liner 22 while liquid waste such as bloodand tumescent solution pass through the filter holes of filter liner 22and are removed into vacuum module 26, typically to be discarded. As aresult, the lipoaspirate received in a liposuction filter canister suchas 10 consists essentially of adipose tissue and is relatively free ofliquid waste such as blood and/or tumescent solution.

Mechanical Processing of the Lipoaspirate

As discussed above, in ‘b’, lipoaspirate inside the liposuction filtercanister is mechanically-processed (in some embodiments, vortex-mixed)to mix the lipoaspirate. The mechanical processing reduces the averagesize of adipose tissue pieces in the lipoaspirate without substantiallyrupturing lipocytes therein. As noted above, any suitable method ofmechanical processing that is sufficient to break-up the pieces ofadipose tissue but is gentle enough to avoid substantial rupturing oflipocytes may be used in implementing the teachings herein. In someembodiments, the mechanical mixing is selected from the group consistingof: vortex mixing the lipoaspirate in the canister; vibrating thelipoaspirate in the canister; and mechanically-mixing the lipoaspiratein the canister.

For brevity and clarity, the description that follows will discuss anembodiment where the mechanical processing is vortex-mixing. Thedescription is applicable, mutatis mutandis, for other methods ofmechanical processing.

In ‘b’, vortex-mixing is applied to the lipoaspirate that is held insidethe liposuction filter canister, thereby vortex-mixing the lipoaspirate.Any suitable method and/or device may be used for vortex-mixing of thelipoaspirate.

In some embodiments, the vortex-mixing is by a vortex-mixing unit onwhich the bottom of the filter canister container rests. FIGS. 2A, 2Band 2C depict embodiments having a vortex-mixing unit 32 on which thebottom of the container of filter canister 10 rests.

Alternatively or additionally, in some embodiments, the vortex-mixing isby a vortex-mixing unit which at least partially encircles at least aportion of the filter canister container. FIGS. 2B, 2C and 2D depictembodiments having a vortex-mixing unit 32 which at least partiallyencircles at least a portion of a filter canister 10. It is important tonote that FIGS. 2, 3 and 4B-4H are drawn so that there is a gap betweenthe bottom of a canister 10 and components of the depicted device, e.g.,mixing unit 32. The gap is drawn for clarity and, in practice, thecanister physically contacts the component.

As known to a person having ordinary skill in the art, a vortex-mixingunit is a unit that produces and applies motion to a vessel in which afluid is held (e.g., a filter canister in which lipoaspirate is held),the applied motion inducing the formation of a vortex in the fluid, thevortex effective for mixing the fluid. In some embodiments, avortex-mixing unit used for implementing the teachings herein includesan engagement component that transfers at least some of thevortex-inducing motion produced by the vortex-mixing unit to a filtercanister held by the filter canister holder when the vortex-mixing unitis activated.

In FIG. 2A, a flat bottom 34 of filter canister 10 is depicted restingon a flat upper surface 36 of vortex-mixing unit 32. In FIG. 2A, flatupper surface 36 of vortex-mixing unit 32 is defined by the uppersurface of the engagement component thereof, a rubber mat 38. Whenvortex-mixing unit 32 is activated, vortex-stirring inducing motion istransferred to filter canister 10 through the engagement component,rubber mat 38. In some similar embodiments, the engagement component ismade of a material different from rubber, e.g., plastic or silicone.

In FIG. 2B, a flat bottom 34 of filter canister 10 is depicted restingon a flat upper surface 36 of vortex-mixing unit 32 while an engagementcomponent, a rubber ring 40, of vortex-mixing unit 32 encircles thebottom of filter canister 10. When vortex-mixing unit 32 is activated,vortex-stirring inducing motion is transferred to filter canister 10,inter alia, by the engagement component, rubber ring 40. In FIG. 2B,rubber ring 40 constituting an engagement component completely encirclesthe entire bottom of filter canister 10. In some similar embodiments,the engagement component encircles only a portion of the bottom of afilter canister, e.g., is an incomplete ring. In some similarembodiments, the engagement component is made of a material differentfrom rubber, e.g., plastic, silicone or metal.

In FIG. 2C, a non-flat (conical) bottom 42 of filter canister 10 isdepicted resting on a non-flat upper surface 44 of vortex-mixing unit32. Non-flat upper surface 44 of vortex-mixing unit 32 on which filtercanister 10 rests and which encircles the bottom portion of filtercanister 10, constitutes an engagement component of vortex-mixing unit32. When vortex-mixing unit 32 of the device depicted in FIG. 2C isactivated, vortex-stirring inducing motion is transferred to filtercanister 10, inter alia, through the engagement component, non-flatupper surface 44. Some such embodiments having a non-flat bottom as anengagement component have an additional engagement component, forexample the embodiment depicted in FIG. 2C also has a rubber ring 40 asan additional engagement component. Some embodiments similar to thedepicted in FIG. 2C have a non-flat bottom as an exclusive engagementcomponent.

In FIG. 2D, a flat bottom 34 of filter canister 10 is depicted restingon the smooth surface of a flat supporting shelf 46. The engagementcomponent of vortex-mixing unit 32 depicted in FIG. 2D is a rubber-linedring 48 which encircles the sides of filter canister 10. Whenvortex-mixing unit 32 is activated, vortex-stirring inducing motion istransferred to filter canister 10 through the sides thereof by theengagement component, rubber-lined ring 48. In FIG. 2D, rubber-linedring 18 constituting an engagement component completely encircles thesides of filter canister 10. In some similar embodiments, the engagementcomponent encircles only a portion of a filter canister, e.g., is anincomplete ring. In some similar embodiments, the engagement componentis made of a material different from a rubber-lined ring, e.g., a ringlined with plastic, silicone or metal or an unlined ring made ofplastic, rubber, silicone or metal.

Since the mechanical processing such as vortex-mixing is performed in aliposuction filter canister, the processing of the lipoaspirate,depending on the embodiment, is performed concurrently with the actualharvesting and/or very soon after the actual harvesting is completedunder aseptic conditions as there is no need to transfer thelipoaspirate from the filter canister for processing. It is believedthat mechanically-processing the lipoaspirate concurrently with theharvesting and/or soon after harvesting thereof is advantageous: withoutwishing to be held to any one theory, it is currently hypothesized thatquick processing leads to less stress on the harvested adipose tissue.Accordingly, in some embodiments the mechanical processing is startedwithin 60 minutes of the harvesting of the lipoaspirate. In someembodiments, the mechanical processing is performed within 45 minutes,within 30 minutes, within 15 minutes within 10 minutes, within 5minutes, within 1 minute, within 30 seconds within 5 seconds and evenconcurrently with the harvesting of the lipoaspirate.

In some embodiments, the mechanical processing such as vortex-mixing isapplied to the lipoaspirate with no additional material added into theliposuction filter canister. In some alternative embodiments, a volumeof aqueous solution is added (e.g., through an access port 20 or othersuitable component) to the liposuction filter canister prior and/orduring application of the mechanical processing. It has been found that,in some embodiments (such as some embodiments of vortex mixing), theaddition of an aqueous solution increases the efficacy of the mechanicalprocessing, improving the results thereof. In such embodiments, theaqueous solution is preferably sterile. In some such embodiments, theaqueous solution is isotonic. Examples of suitable aqueous solutionsinclude PBS (phosphate-buffered solution), saline and Ringer’s solution.If added, the amount of aqueous solution is any suitable amount and insome embodiments is not more than 100%, not more than 80%, not more than60% and even not more than 50% of the volume of lipoaspirate containedin the filter canister. In some embodiments, the amount of aqueoussolution added is at least partially dependent on the characteristics ofthe container of the filter canister: the amount of aqueous solutionadded is such that not less than about 30%, not less than about 50% andeven not less than about 65% of the lipoaspirate is below the level ofthe aqueous solution added to the filter canister. In preferred suchembodiments, during the draining ‘c’, added aqueous solution is alsodrained from the liposuction filter canister.

Parameters of the Mechanical Processing

The parameters of the mechanical processing are any suitable parametersthat achieve the desired effect. It is desirable that the mechanicalprocessing be intensive enough to cause the pieces of lipid tissue inthe lipoaspirate to fall apart sufficiently to release a substantialamount of beneficial factors from the tissue, but not so intensivelythat substantial amounts of harmful factors are released and/or that asubstantial number of lipocytes are damaged.

In some embodiments vortex-mixing is performed at not more than 3000rpm. In some embodiments, vortex-mixing is performed at not more than1000 rpm, not more than 800 rpm and even not more than 700 rpm. Thatsaid, in some embodiments vortex-mixing is performed at not less than 60rpm and even not less than 100 rpm.

Generally speaking, the duration of vortex-mixing is preferably as shortas possible to save time, thereby making efficient use of the devicesused for processing the lipoaspirate but sufficiently long so that asubstantial amount of beneficial factors are released from the tissue.In some embodiments, vortex-mixing is performed for not more than 30minutes, not more than 20 minutes, not more than 10 minutes and even notmore than 7 minutes. In some embodiments, vortex-mixing is performed fornot less than 30 seconds and even not less than 60 seconds.

Draining of Released Fluid

In ‘c’, subsequent to the mechanical processing, fluid released from thelipoaspirate as a result of the mechanical processing is removed fromthe liposuction filter canister. The released fluid contains harmfulfactors released from the lipoaspirate by the mechanical processing aswell as remnants of blood and/or tumescent solution and, if present, anyaqueous solution added to assist in the mechanical processing.Importantly, what remains trapped in the filter liner (22 in FIG. 1 ) isclean adipose tissue suitable for AFT that is somewhat enriched withbeneficial factors. Although not wishing to be held to any one theory,it is currently hypothesized that the mechanical processing such asvortex-mixing gently breaks apart pieces of adipose tissue held in thefilter canister, releasing beneficial factors that are ordinarilyconsidered components of an SVF. Further, the mechanical processing suchas vortex-mixing is apparently sufficiently gentle that it leads to theproduction and/or release of fewer harmful factors than is releasedduring known methods of processing lipoaspirate. The mechanicalprocessing such as vortex-mixing is also effective in removing at leastsome of the harmful factors (whether previously present or released as aresult of the mechanical processing) that have passed through the filterliner.

In some embodiments, for draining the released fluid, the filtercanister is detached from the liposuction vacuum module (22 in FIG. 2A)of the liposuction device and the filter canister containing thelipoaspirate is moved to another location for mechanical processingand/or for draining the released fluid. For example, in someembodiments, the filter canister is detached from the liposuction vacuummodule of the liposuction device and is moved to a desired mechanicalprocessing device for mechanical processing, for example, to a vortexmixer for vortex-mixing. In such embodiments, any suitable device andmechanism may be used for mechanically processing the lipoaspirate inthe filter canister, in some embodiments, devices and/or mechanismsanalogous to those depicted in FIGS. 2A - 2D, 3A-3C and 4A-1, 4A-2,4A-3, 4A-4 and 4B to -4H.

In some such embodiments, during the mechanical processing such asvortex-mixing, the filter canister is not attached (i.e., “attached”being an adjective) to a fluid drainage mechanism such as theliposuction vacuum module of the liposuction device. In suchembodiments, subsequently to the mechanical processing, the filtercanister containing the lipoaspirate is reattached to a fluid drainagemechanism to drain the fluid released from the lipoaspirate, forexample, is reattached to the liposuction vacuum module of theliposuction device.

In preferred embodiments, the liposuction filter canister is attached(i.e., “attached” being an adjective) to a fluid drainage mechanismduring the mechanical processing. In some such embodiments, during themechanical processing, the filter canister is attached to a fluiddrainage mechanism that is not the liposuction vacuum module of theliposuction device. In preferred embodiments, the filter canisterremains connected to the liposuction vacuum module of the liposuctiondevice to serve as the fluid drainage mechanism. In such embodiments,draining the fluid released from the lipoaspirate as a result of themechanical processing is preferably performed by activating theliposuction vacuum module.

AFT with the Mechanically Processed Adipose Tissue

In some embodiments, the method further comprises subsequent to thedraining ‘c’, transferring the lipoaspirate from the filter canister toan autologous fat transfer (AFT) device. An AFT device is any device orcomponent of a device that is used for transplanting fat to a livingsubject, e.g., a syringe or a syringe barrel. In some embodiments,lipoaspirate is transferred directly, that is to say, from the filtercanister to the AFT device. In some embodiments, lipoaspirate istransferred indirectly, e.g., from the filter canister to a containerand from the container to the AFT device. For example, in someembodiments, a syringe 56 (as an AFT device such as a fattransplantation device or a container) is inserted through open accessport 20 to remove the vortex-mixed adipose tissue.

In some embodiments, the method further comprises transplanting thelipoaspirate to a living subject using the AFT device, preferably to thesame subject from whom the adipose tissue was harvested (autologously).In some embodiments, transplanting the lipoaspirate to a living subjectis not part of the claimed invention.

Washing of the Mechanically Processed Adipose Tissue

As noted above, as a consequence of the mechanical processing, a fluidis released from the lipoaspirate and passes through the filter liner(22 in FIG. 1 ) to gather in the container (12 in FIG. 1 ) of the filtercanister 10. The released fluid contains harmful materials released fromthe lipoaspirate as a result of the mechanical processing as well asremnants of blood and/or tumescent solution.

In some embodiments, subsequent to the mechanical processing of thelipoaspirate ‘b’ and preferably also subsequent to the draining of fluid‘c’ (if done) but prior to the transferring of the vortex-mixedlipoaspirate to an AFT device, the method further comprises washing themechanically-processed lipoaspirate by adding a washing solution (e.g.,saline, Ringer’s solution, PBS) to the filter canister and draining fromthe container in the usual way, e.g., by activating a fluid drainagemechanism such as the liposuction vacuum module or, in some embodiments,a separate drainage module. Such washing helps remove at least some ofthe harmful materials from the lipoaspirate. Such a washing solution ispreferably sterile and/or isotonic.

In some preferred embodiments, subsequent to the mechanical processingof the lipoaspirate ‘b’ and preferably also subsequent to the drainingof fluid ‘c’ (if done) but prior to the transferring of themechanically-processed lipoaspirate to an AFT device, themechanically-processed lipoaspirate in the liposuction filter canisteris not washed. Additionally or alternatively, in some preferredembodiments, subsequent to the mechanical-processing of the lipoaspirate‘b’ and preferably also subsequent to the draining of fluid ‘c’ (ifdone) but prior to the transferring of the mechanically-processedlipoaspirate to an AFT device, the mechanically-processed lipoaspiratein the liposuction filter canister is not centrifuged. Not having awashing step and/or a centrifugation step has numerous advantagesincluding saving time and cost, inter alia by simplifying the devicethat is used for processing the lipoaspirate, obviating the need forproviding a washing solution and reducing the amount of biological wastethat needs to be disposed of. Surprisingly, embodiments of AFT performedusing not-washed / not-centrifuged lipoaspirate that ismechanically-processed in accordance with the teachings herein arehighly successful. This success indicates that the mechanical-processingreleases sufficient beneficial materials that remain in the lipoaspirateto enrich the lipoaspirate. In parallel, sufficient harmful materialsare removed from the lipoaspirate through the filter of the liposuctionfilter canister so as not to substantially reduce the quality of thelipoaspirate for AFT.

Capacity of Filter Canister and Volume of Lipoaspirate Processed

A person having ordinary skill in the art is aware that in the acceptedprior art methods of processing lipoaspirate, improved AFT isnecessarily performed only with low volumes of enriched adipose tissue,around 100 ml. This is a result of the complexity of producing an SVFfor enriching the adipose tissue including vigorous mechanical and/orenzymatic processing of a portion of the lipoaspirate, followed bycentrifugation to produce a 1-gram SVF pellet. The produced SVF pelletis then washed and subsequently added to a relatively small volume ofadipose tissue (typically around 100 ml) that is thereby enriched andused for improved AFT.

According to the teachings herein, any desired volume of lipoaspiratecontained inside the liposuction filter canister is processed byapplication of mechanical processing such as vortex-mixing to produceenriched lipoaspirate, limited only by the volume of the liposuctionfilter canister and by the amount of adipose tissue harvested from thesubject.

Accordingly, in some embodiments, the liposuction filter canistercontaining the lipoaspirate has a volume of not less than 50 ml and notmore than 10 liter and even not more than 5 liter. In some embodiments,the liposuction filter canister is selected from the group consisting ofsmall-sized having a volume of not less than 50 ml and not more than 100ml, medium-sized having a volume of not less than 100 ml and not morethan 500 ml, large-sized having a volume of not less than 500 ml and notmore than 1 liter and very large-sized having a volume of not less than1 liter.

In some embodiments the amount of received harvested lipoaspiratecontained in the liposuction filter canister is not less than 50 ml andnot more than 10 liter. In some embodiments the amount of receivedharvested lipoaspirate contained in the liposuction filter canister isselected from the group consisting of not less than 50 ml and not morethan 100 ml, not less than 100 ml and not more than 500 ml, not lessthan 500 ml and not more than 1 liter and even not less than 1 liter.

Enzymatic Processing

As discussed in the introduction, it is known to process lipoaspirate byaddition of external enzymes to release stem cells and the like from theadipose tissue. In preferred embodiments of the teachings herein, noexternal enzyme is added to the lipoaspirate from the time of theharvesting through the draining of the fluid released from thelipoaspirate ‘c’ and, if applicable, through the transferring of thelipoaspirate to an AFT device. In some such preferred embodiments thelipoaspirate is devoid of contact with any external enzyme from prior to‘a’ through immediately subsequent to ‘b’ and prior to ‘c’. In some suchpreferred embodiments the lipoaspirate is devoid of contact with anyexternal enzyme from prior to ‘a’ through immediately subsequent to ‘c’.In some such preferred embodiments the lipoaspirate is devoid of contactwith any external enzyme as long as the lipoaspirate is contained in theliposuction filter canister.

Liposuction

The teachings of the method herein are based on the discovery thatgentle mechanical processing of harvested lipoaspirate allows forprocessing harvested lipoaspirate in a liposuction filter canister,yielding an enriched lipoaspirate for improved AFT.

It is currently believed that the processing method according to theteachings herein is exceptionally suitable for use together withhigh-quality lipoaspirate, that is to say, lipoaspirate that washarvested gently with relatively less trauma which results in less wastematerial such as blood, fewer dead or damaged lipocytes (also calledadipocytes) and fewer traumatized lipocytes. Without being held to anyone theory, it is believed that such a gently-harvested lipoaspirateincludes fewer harmful factors. Accordingly, in some embodiments, thereceived lipoaspirate is lipoaspirate harvested using a gentleliposuction method and/or device.

In some embodiments, the gentle liposuction method isultrasound-assisted liposuction and liposuction was performed using anultrasound-assisted liposuction device.

In some embodiments, the gentle liposuction method is radio frequency(RF)-assisted liposuction and liposuction was performed using anRF-assisted liposuction device.

In some embodiments, the lipoaspirate was harvested using a cannula withan internal diameter of at least 2 mm and not more than 5 mm.

In some embodiments, the lipoaspirate was harvested using a suctionpressure of at least 20 kP and not more than 98 kP.

In some embodiments of the method, the received lipoaspirate isharvested from a subject using laser-assisted liposuction using alaser-assisted liposuction device, as depicted in FIGS. 2A-2D. In somesuch embodiments, the laser-assisted liposuction is performed using alaser wavelength within the range of 800 - 1600 nm, 1400 - 1500 nm,1450 - 1490 nm and even 1460 - 1480 nm, for example a laser wavelengthof 1470 nm as is used in some commercially-available laser-assistedliposuction devices such as LipoLife® by Alma Lasers (Caesarea, Israel).In some such embodiments, the laser-assisted liposuction is performedusing a radially-irradiating optical fiber as is used in somecommercially-available laser-assisted liposuction devices such asLipoLife® by Alma Lasers.

Without wishing to be held to any one theory, it is currently believedthat laser-assisted liposuction, especially using the above-recitedwavelengths and/or a radially-irradiating optical fiber, is very gentleand produces fewer harmful factors than other liposuction methods.

Additional Processing of the Lipoaspirate

As noted above, subsequent to the mechanical processing ‘b’ or thedraining of released fluid ‘c’, the processed lipoaspirate inside theliposuction filter canister is typically ready for use in AFT, with orwithout a subsequent washing step.

That said, in some instances, subsequent to ‘c’ the processedlipoaspirate is insufficiently fluid for some types of AFT, typicallyindicating that the processed lipoaspirate includes a relatively largeproportion of relatively large pieces of adipose tissue. Further, insome instances it is desired to additionally or alternatively produce anSVF for use, either to enrich lipoaspirate for AFT or for othertherapeutic purposes.

It has been found by the Inventors that it is possible to furtherprocess the lipoaspirate contained in the liposuction filter canistersubsequent to draining ‘c’, yielding a more fluid lipoaspirate that issuitable for AFT and/or an SVF. Thus, in some embodiments the methodfurther comprises:

d. subsequent to ‘c’, applying additional mechanical processing such asvortex-mixing to the lipoaspirate contained in the liposuction filtercanister to mix the lipoaspirate, the additional mechanical processingreducing the average size of adipose tissue pieces in the lipoaspiratewithout substantially rupturing lipocytes therein.

The parameters of the additional mechanical processing (including: timesubsequent to harvesting, addition or no addition of additional materialto the liposuction filter canister, the intensity at which themechanical processing is performed, the duration the mechanicalprocessing is performed) are as described above for the vortex-mixing of‘b’ (and herein for other mechanical processing methods) and, forreasons of brevity, not recited again.

In some embodiments, the additional mechanical processing ‘d’ isperformed subsequent to ‘c’ on the entire contents of the liposuctionfilter canister. In some alternate embodiments, subsequent to ‘c’ someof the lipoaspirate is removed from the liposuction filter canister andthe additional mechanical processing is performed only on thelipoaspirate remaining in the liposuction filter canister. In someembodiments, the type of mechanical processing in ‘b’ is different fromthe type of mechanical processing in ‘d’. For simplicity, in preferredembodiments the type of mechanical processing in ‘b’ is the same as thetype of mechanical processing in ‘d’.

Fluid Lipoaspirate

It has been found that subsequent to ‘d’, the additional mechanicalprocessing of the lipoaspirate renders the lipoaspirate more fluid andtherefore suitable, in some embodiments, for AFT in finer regions of thebody or for finer definition of the body. It is currently believed thatthe additional mechanical processing reduces the average size of thepieces of adipose tissue making up the lipoaspirate. It is also believedthat additional beneficial factors are released while relatively fewharmful factors are released, so that the lipoaspirate is consideredenriched for use in improved AFT.

Accordingly, in some embodiments, the method further comprises:subsequent to the additional mechanical processing ‘d’, transferring thelipoaspirate to an autologous fat transfer (AFT) device. In someembodiments, lipoaspirate is transferred directly, that is to say, fromthe filter canister to the AFT device. In some embodiments, lipoaspirateis transferred indirectly, e.g., from the filter canister to a containerand from the container to the AFT device. In some embodiments, themethod further comprises transplanting the liposuction to a livingsubject using the AFT device, preferably to the same subject from whichthe adipose tissue was harvested (i.e., autologously).

Stromal Vascular Factor

As with the first mechanical processing ‘b’, the additional mechanicalprocessing ‘d’ releases a fluid that passes through the filter liner ofthe liposuction filter canister. It has been found that this fluid isenriched with beneficial factors such as stem cells which can begathered and concentrated in the usual way to make an SVF pellet.

Accordingly, in some embodiments the method further comprises:

e. subsequent to the additional mechanical processing ‘d’, isolatingfluid released from the lipoaspirate consequent to the additionalmechanical processing as an SVF fluid.

In some embodiments, the SVF fluid is processed to make an SVF pellet.In some such embodiments, such processing includes placing the SVF fluidin a centrifugation vessel and centrifuging the SVF fluid in thecentrifugation vessel to yield an SVF pellet at the bottom of thecentrifugation vessel. The SVF pellet can be used in the usual way, forexample, is suspended in a fluid as an injectable therapeutic or isadded to adipose tissue / lipoaspirate to enrich adipose tissue for AFT,including lipoaspirate processed in accordance with the teachingsherein.

Device for Implementing The Method

Embodiments of the method according to the teachings herein can beperformed using a suitable device or combination of devices, asdiscussed hereinabove. Some embodiments are preferably implemented usinga liposuction device according to the teachings herein, such as device24 discussed with reference to FIGS. 2A - 2D above or the devicesdepicted in FIGS. 3A-3C or FIGS. 4A-1, 4A-2, 4A-3, 4A-4 and 4B to 4H. Insome embodiments, such a liposuction device is substantially aliposuction device 24 configured for performing liposuction, the devicecomprising a vortex mixing unit as a lipoaspirate-processing unit (e.g.,32 depicted in FIGS. 2A-2D), the vortex-mixing unit configured, whenactivated, to produce and apply vortex-inducing motion at an intensityand for a duration to a liposuction filter canisterfunctionally-associated with the liposuction device to implement one ormore embodiments of the method according to the teachings herein. Suchvortex-inducing motion induces the formation of a vortex in the contentsof the liposuction filter canister, thereby vortex-mixing the contentsof the liposuction filter canister.

As discussed above, embodiments of such a device can include one or moreof:

-   a liposuction vacuum module, such as known in the art, to effect    liposuction and in some embodiments that can function as a fluid    drainage module to remove liquids from a liposuction filter canister    such as fluids released from lipoaspirate as a result of the    vortex-mixing;-   a fluid drainage module that is different from the liposuction    vacuum module to remove liquids from a liposuction filter canister    such as fluids released from lipoaspirate as a result of the    vortex-mixing;-   a liposuction probe having a distal end attachable to a liposuction    cannula and a proximal end attachable to a liposuction filter    canister functionally-associated with the liposuction device through    an aspirate inlet thereof, configured to direct liposuction aspirate    harvested via a liposuction cannula from said distal end through    said proximal end into a container of the attached liposuction    filter canister;-   a washing module attachable to a liposuction filter canister    functionally-associated with the liposuction device through an    access port thereof, configured to add an amount of liquid (e.g.,    washing solution) into a container of the attached liposuction    filter canister (preferably a metered amount of liquid); and-   a controller configured to automatically process lipoaspirate    (preferably in accordance with an embodiment of the method according    to the teachings herein) contained in a liposuction filter canister    functionally associated with the liposuction device, the automatic    processing comprising activation of the vortex-mixing unit, the    fluid drainage module (in some embodiments where the fluid drainage    module is the same as the liposuction vacuum module and in other    embodiments where the fluid drainage module is different from the    liposuction vacuum module) and the washing module in a desired    order, preferably in accordance with an embodiment of the teachings    herein. A person having ordinary skill in the art is able to    implement a controller with no inventive effort upon perusal of the    description. Typically, the controller is implemented as series of    commands to the modules (implemented in software, hardware and/or    firmware) on a computer (custom or general purpose, e.g., the    computer that also functions as a controller to operate the    liposuction device to perform liposuction), communication devices    and protocols to the various controlled modules and, in some    embodiments, electrical and/or electromechanical components such as    switches, solenoids and robotic arms.

Liposuction device 24 depicted in FIG. 2A includes a controller 50 and awashing module 52. Liposuction vacuum module 26 is configured also tofunction as a fluid drainage module.

Mechanical Processing by Vibration

As noted above, in some embodiments the method is implemented where themechanical processing is vibration.

Similarly, in some embodiments, the lipoaspirate processing unit of adevice according to the teachings herein comprises a vibration unit(instead of or in addition to a vortex-mixing unit), the vibration unitconfigured, when activated, to produce and apply vibrations tolipoaspirate contained inside a liposuction filter canisterfunctionally-associated with the liposuction device, the vibrationseffective to mechanically process the lipoaspirate.

The applied vibrations are of any suitable frequency and intensity toachieve the desired balance of mechanical processing withoutsubstantially rupturing lipocytes. A person having ordinary skill in theart is able to determine a suitable frequency and intensity to achievethe desired effect without undue experimentation.

It is known in the art that vibrations having ultrasonic frequencieshigher than 20 kHz cause in vitro cell lysis. Accordingly, in someembodiments the applied vibrations have a frequency of less than 20 kHz,less than 10 kHz and even less than 5 kHz. Suitable devices forgenerating suitable frequencies include commercially-availablelow-frequency sonic transducers, e.g., from Sensor Technology Ltd.(Collingwood, Ontario, Canada).

In some embodiments, the vibration unit and/or a controller of theliposuction device are configured to allow vibration of the contents ofa liposuction filter canister functionally-associated with theliposuction device for a period of not more than 30 minutes, not morethan 20 minutes, not more than 10 minutes and even not more than 7minutes.

In some embodiments, the vibration unit and/or the controller areconfigured to allow vibration of the contents of a liposuction filtercanister functionally-associated with the liposuction device for aperiod of not less than 30 seconds and even not less than 60 seconds.

FIGS. 3A-3C are schematic depictions of components of embodiments ofdevices useful for implementing embodiments of the methods according tothe teachings herein where the mechanical processing is vibration,liposuction devices 58 including a vibration unit 60 as a lipoaspirateprocessing unit.

Sonic Transmitter Probe

In some embodiments, the vibration unit comprises at least one sonictransmitter probe configured to be positioned inside a volume enclosedby a filter liner of a liposuction filter canisterfunctionally-associated with the liposuction device. As is known in theart of sonic treatment, a sonic transmitter probe is a device thatproduces vibrations and transfers the vibrations to a medium, e.g., thelipoaspirate according to the teachings herein. In such embodiments,during use the probe is at least partially immersed in the lipoaspirate.

In some embodiments, the vibration unit comprises a single sonictransmitter probe. An advantage of single transmitter probe issimplicity. In FIG. 3A is depicted a filter canister 10 in crosssection, functionally associated with a device 58. Positioned insideinner volume 23 of canister 10 is an elongated sonic transmitter probe62 so that when volume 23 contains a fluid such as lipoaspirate, probe62 is immersed therein. Sonic transmitter probe 62 is functionallyassociated with the controller (not depicted) of device 58 through cable64. When required, the controller provides the required power for therequired duration so that probe 62 produces vibrations for processinglipoaspirate contained in volume 23 in accordance with the teachingsherein.

In some embodiments, the vibration comprises at least two, at leastthree and even at least four sonic transmitter probes. An advantage oftwo or more sonic probes is that the mechanical processing caused by thevibration of the probes is more effectively distributed in the entirevolume of the lipoaspirate. In some embodiments, one or more of thesonic transmitter probes are elongated. In FIG. 3B is depicted a filtercanister 10 functionally associated with a device 58. Device 58 depictedin FIG. 3B is the same as depicted in FIG. 3A but includes two elongatedsonic transmitter probes 62 a and 62 b.

In some such embodiments, some or all of a sonic transmitter probe is acomponent of a liposuction filter canister and the liposuction device isconfigured, for example includes electrical connectors, to allowoperation of the sonic transmitter probe of the liposuction canister inaccordance with the teachings herein. Alternatively or additionally, insome embodiments, some or all of a sonic transmitter probe is acomponent of the liposuction device.

In some embodiments, the probe is covered with a cover such as sheathfor use to prevent non-sterile contact of the probe with lipoaspirate.In some embodiments, at least the outer portion of the probe is disposedafter use.

Vibrating Filter Liner

In some embodiments, the vibration unit comprises a sonic transmitterconfigured to physically-associated with a filter liner of a liposuctionfilter canister functionally-associated with the liposuction device sothat when activated, said sonic transmitter causes aphysically-associated filter liner to vibrate. In such embodiments, thevibrating filter liner transfers the vibrations from the sonictransmitter to the lipoaspirate held therein. In such embodiments, atleast part of the filter liner is made of a material that transferssonic vibrations such as a medical grade metal or a medical gradeplastic such as polyester. In some such embodiments, the sonictransmitter is a component of a liposuction filter canister and theliposuction device is configured, for example includes electricalconnectors, to allow operation of the sonic transmitter of theliposuction canister in accordance with the teachings herein.Alternately, in some such embodiments, the sonic transmitter is acomponent of the device and the liposuction filter canister is aseparate component, where the two are configured to allow reversiblesonic mating of the transmitter with the filter liner.

In FIG. 3C is depicted a filter canister 10 functionally associated witha device 58. Functionally associated with filter liner 22 of canister 10is a sonic transmitter 66 functionally associated with the controller(not depicted) of device 58 through cable 64. When required, thecontroller provides the required power for the required duration so thattransmitter 66 produces vibrations that are transferred by filter liner22 to lipoaspirate contained in volume 23 to process the lipoaspirate.

In some embodiments, sonic transmitter 66 is a component of device 58that is reversibly coupled with filter liner 22 through a connector 68.

In some alternate embodiments, sonic transmitter 66 is a component ofcanister 10 that is reversibly coupled with device 58 through cable 64through a connector 70.

Mechanical Mixing

As noted above, in some embodiments the method is implemented where themechanical processing is mechanical mixing.

Similarly, in some embodiments, the lipoaspirate processing unit of adevice according to the teachings herein comprises:

-   a mechanical mixing component configured to be positioned inside a    volume enclosed by a filter liner of a liposuction filter canister    functionally-associated with the liposuction device; and-   a mixing motor configured to move lipoaspirate contained in the    volume relative to the mechanical mixing component to    mechanically-mix the lipoaspirate, the mechanical mixing effective    to mechanically process the lipoaspirate.

FIGS. 4A-1, 4A-2, 4A-3, 4A-4 and 4B to 4H are schematic depictions ofcomponents of embodiments of devices useful for implementing embodimentsof the methods according to the teachings herein, the devices configuredfor mechanical mixing.

Translation Mixing Component

In some embodiments, a mixing motor is configured so that the relativemotion of the mechanical mixing component to the liposuction filtercanister is translation in parallel to the longitudinal axis of theliposuction filter canister. In some embodiments, the filter canister ismoved in parallel to the longitudinal axis. Additionally oralternatively, in some embodiments, the mechanical mixing component ismoved in parallel to the longitudinal axis.

In some such embodiments, the mixing component is a flow-restrictingbarrier, that is to say, the mixing component constitutes a partialbarrier to flow of lipoaspirate therethrough. As a result of thetranslation of the canister relative the mixing component, lipoaspiratecontained in the inner volume of the filter liner passes through and/oralongside the mixing component (between the mixing component and thefilter liner) in a restricted, increased-pressure, flow which leads tomechanical mixing of the lipoaspirate that is effective tomechanically-process the lipoaspirate.

In some such embodiments, the flow-restricting barrier comprises or is apartially-pervious plunger. As used herein, a partially-pervious plungeris a flow-restricting barrier having a small dimension parallel to thelongitudinal axis and a larger dimension perpendicular to thelongitudinal axis which is partially-pervious, that is to say,configured to allow lipoaspirate contained in the inner volume of thefilter liner to pass through the plunger or alongside the plunger(between the plunger and the filter liner itself). A partially-perviousplunger is contrasted with an impervious plunger, a component of priorart syringes that does not allow a fluid to pass therethrough oralongside.

In some embodiments, the outline of a partially-pervious plunger in thedimension perpendicular to the longitudinal axis 13 is round, e.g.,plunger 66 a in cross-section from above in FIG. 4A-1 , a solid thinplate that has a diameter smaller than the inner diameter of liner 22 sothat during translation lipoaspirate passes in the space between the rimof plunger 66 a and the inner wall of liner 22.

In some embodiments, the outline of the plunger in the dimensionperpendicular to the longitudinal axis 13 is indented, e.g.,flower-shaped plunger 66 b in cross-section from above in FIG. 4A-2 , aperforated flower-shaped plate so that during translation lipoaspiratepasses in the space between the indentations and through theperforations.

In some embodiments, the outline of the plunger in the dimensionperpendicular to the longitudinal axis 13 is the same as the profile ofthe inner wall of the liner such as plunger 66 a in FIG. 4A-1 .

In some embodiments, the outline of the plunger in the dimensionperpendicular to the longitudinal axis 13 is different from the profileof the inner wall of the liner such as plunger 66 b in FIG. 4A-1 orplunger 66 c in cross section from above in FIG. 4A-3 .

In some embodiments, the plunger is devoid of gaps that allow passage oflipoaspirate therethrough such as plunger 66 a in FIG. 4A-1 or 66 c inFIG. 4A-3 .

In some embodiments, the plunger is perforated such as perforatedplunger 66 b in FIG. 4A-2 or mesh plunger 66 d in FIG. 4A-4 wherelipoaspirate can pass through the mesh 67 that constitutes portions ofplunger 66 d in a manner analogous to a French press.

The speed of the relative translational motion is any suitable speed andis typically dependent on the characteristics of the mixing component:e.g., more restrictive barriers are moved more slowly while lessrestrictive barriers are moved more quickly. In some preferredembodiments, the speed is between 1 mm/sec to 10 cm/sec. In someembodiments, the device (e.g., the controller) is configured so that themovement is performed only once in one direction (e.g., from top tobottom or from bottom to top). In some alternate embodiments, themovement is performed at least twice (e.g., from top to bottom and backto the top, or from bottom to top and back to the bottom).

In FIG. 4B is depicted a liposuction device 68 functionally-associatedwith a filter canister 10. Inside an inner volume 23 defined by filterliner 22 is a mechanical mixing component, comprising a pervious plunger66 and rigid straight support bar 70 parallel with longitudinal axis 13and fixed to device 68. A mixing motor 72 is configured to move filtercanister 10 in parallel to axis 13 while partially-pervious plunger 66and bar 70 do not move so that lipoaspirate in volume 23 is forced pastand/or through plunger 66 to be mixed and thereby mechanicallyprocessed.

In FIG. 4C is depicted a liposuction device 74 similar to device 68. Indevice 74, filter canister 10 is fixed in place relative to device 74and mixing motor 72 is configured to move partially-pervious plunger 66and rigid straight support bar 70 parallel with longitudinal axis 13.

Rotating Filter Liner Mixing Component

Alternately or additionally to translation mixing, in some embodiments,a mixing motor is configured to rotate the filter liner relative to acontainer of the liposuction filter canister around an axis parallel tothe longitudinal axis of the liposuction canister. In some suchembodiments, the mechanical mixing component comprises mixing elementsprotruding from an inner surface of the filter liner into the innervolume, the mixing elements rotating together with the filter liner.Additionally or alternately, in some embodiments the mechanical mixingcomponent comprises mixing elements that do not rotate together with thefilter liner.

In FIG. 4D is depicted a liposuction device 76 functionally-associatedwith a filter canister 10, filter canister 10 depicted in schematiccross-section. Electrical mixing motor 72 is configured when activatedto rotate filter liner 22 via a gear 78 that engages matching gear teeth80 in the upper inner rim of filter liner 22. Protruding from an innersurface of filter liner 22 into inner volume 23 are mixing elements 82,3 mm thick rigid polyethylene paddles. When mixing motor 72 isactivated, filter liner 22 and mixing elements 82 rotate together aroundaxis 13, mixing and thereby mechanically processing lipoaspiratecontained in volume 23.

In FIG. 4E is depicted a liposuction device 84 similar to device 76.Inside inner volume 23 and fixedly mounted to the cap of filter canister10 are stator paddles 86 (of 3 mm thick polyethylene. Operation ofmixing motor 72 of device 84 is similar to that of device 76, but thepresence of stator paddles 86 increases the efficiency of the mechanicalprocessing of the lipoaspirate.

Rotating Mixing Component

Alternately or additionally to translation mixing and/or a rotatingfilter liner, in some embodiments a mixing motor is configured to rotatea mechanical mixing component separate from the filter liner that islocated inside the inner volume of the filter liner, typically but notnecessarily the rotation in a plane perpendicular to the longitudinalaxis of the liposuction filter canister.

Any suitable type or combination of types of mechanical mixing componentseparate from the filter liner may be used.

In some embodiments, the mechanical mixing component comprises animpeller. In some embodiments, the impeller is a radial-flow impeller.Alternatively, in some embodiments the impeller is an axial-flowimpeller. In FIG. 4F is depicted a liposuction device 88functionally-associated with a filter canister 10, filter canister 10depicted in schematic side cross-section. Electrical mixing motor 72 isconfigured when activated to rotate an impeller 90 through axle 92,mixing and thereby mechanically processing lipoaspirate contained involume 23.

Alternately or additionally, in some embodiments the mechanical mixingcomponent comprises a propellor, a mechanical mixing component thatdrives a fluid such as lipoaspirate contained in inner volume 23axially. In FIG. 4G is depicted a liposuction device 94functionally-associated with a filter canister 10, filter canister 10depicted in schematic side cross-section. Electrical mixing motor 72 isconfigured when activated to rotate a propeller 96 through axle 92,mixing and thereby mechanically processing lipoaspirate contained involume 23.

Alternately or additionally, in some embodiments the mechanical mixingcomponent comprises a paddle, a mechanical mixing component having aflat surface that drives a fluid such as lipoaspirate contained in innervolume 23 tangentially to the rotation axis. In FIG. 4H is depicted aliposuction device 98 functionally-associated with a filter canister 10,filter canister 10 depicted in schematic side cross-section. Electricalmixing motor 72 is configured when activated to rotate a paddle 100 (of3 mm thick polyethylene) through axle 92, mixing and therebymechanically processing lipoaspirate contained in volume 23.

In embodiments having a mechanical mixing component (e.g., a rotatingfilter liner and or rotating mixing component separate from the filterliner), the rate and duration at which the mechanical mixing componentis rotated is any suitable rate. In some embodiments, the mechanicalmixing unit and/or a controller are configured to allowmechanical-mixing of the contents of a liposuction filter canisterfunctionally-associated with the liposuction device for a period of notmore than 10 minutes, not more than 5 minutes, not more than 1 minutesand even not more than 1 minute. Additionally, in some embodiments, themechanical-mixing unit and/or the controller are configured to allowmechanical-mixing of the contents of a liposuction filter canisterfunctionally-associated with the liposuction device for a period of notless than 10 seconds and even not less than 15 seconds. In somepreferred embodiments, the rate of rotation of the mechanical mixingcomponent is less than 960 rpm, less than 480 rpm, less than 240 rpm andeven less than 120 rpm.

In some such embodiments, the mixing motor and the entire mechanicalmixing component (e.g., plunger and handle) are components of theliposuction device.

In some such embodiments, the mixing motor and part of the mechanicalmixing component (e.g., handle) are components of the liposuction deviceand part of the mechanical mixing component (e.g., plunger) is part ofthe filter canister.

In some such embodiments, the mixing motor is a component of theliposuction device and the entire mechanical mixing component (e.g.,plunger and handle) are components of the filter canister.

In some such embodiments, the mixing motor and the entire mechanicalmixing component (e.g., plunger and handle) are components of the filtercanister. In some such embodiments, the liposuction device providespower (e.g., electrical power) to operate the mixing motor.Alternatively, in some such embodiments power to operate the electricalmotor is provided from a source different than the liposuction device.

In some embodiments, a liposuction device includes more than one type ofmixing component.

The teachings herein can be advantageously be implemented using any typeof liposuction and liposuction device, but are advantageouslyimplemented using more gentle liposuction devices.

For example, in some embodiments, liposuction device 24 depicted in FIG.2A is an ultrasound-assisted liposuction device and component 54 is anultrasound module including some of the components required to applyultrasound energy to adipose tissue undergoing liposuction.

For example, in some embodiments, liposuction device 24 depicted in FIG.2A is a RF-assisted liposuction device and component 54 is a RF moduleincluding some of the components required to apply radiofrequency energyto adipose tissue undergoing liposuction.

For example, in some embodiments, liposuction device 24 depicted in FIG.2A is a laser-assisted liposuction device and component 54 is a lasermodule including some of the components required to apply laser energyto adipose tissue undergoing liposuction. For example, in someembodiments, the liposuction device is a modified LipoLife®laser-assisted liposuction device by Alma Lasers.

Similarly, in some embodiments any one of liposuction devices 58 (FIGS.3A-3C), device 68 depicted in FIG. 4B), device 74 depicted in FIG. 4C),device 76 depicted in FIG. 4D), device 84 depicted in FIG. 4E), device88 (FIG. 4F), device 94 (FIG. 4G), or device 98 (FIG. 4H) are one of anultrasound-assisted liposuction device, RF-assisted liposuction deviceor laser-assisted liposuction device.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which the invention pertains. In case of conflict, thespecification, including definitions, takes precedence.

As used herein, the terms “comprising”, “including”, “having” andgrammatical variants thereof are to be taken as specifying the statedfeatures, integers, steps or components but do not preclude the additionof one or more additional features, integers, steps, components orgroups thereof.

As used herein, the indefinite articles “a” and “an” mean “at least one”or “one or more” unless the context clearly dictates otherwise.

As used herein, when a numerical value is preceded by the term “about”,the term “about” is intended to indicate +/-10%.

As used herein, a phrase in the form “A and/or B” means a selection fromthe group consisting of (A), (B) or (A and B). As used herein, a phrasein the form “at least one of A, B and C” means a selection from thegroup consisting of (A), (B), (C), (A and B), (A and C), (B and C) or (Aand B and C).

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable sub combination or as suitable in any other describedembodiment of the invention. Certain features described in the contextof various embodiments are not to be considered essential features ofthose embodiments, unless the embodiment is inoperative without thoseelements.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the scope of the appendedclaims.

Citation or identification of any reference in this application shallnot be construed as an admission that such reference is available asprior art to the invention.

Section headings are used herein to ease understanding of thespecification and should not be construed as necessarily limiting.

What is claimed is:
 1. A liposuction device configured for performingliposuction by drawing in vivo adipose tissue from a body as alipoaspirate through a cannula and transferring at least some theharvested adipose tissue into a liposuction filter canister functionallyassociated with the liposuction device, the device comprising: alipoaspirate processing unit, said lipoaspirate processing unitconfigured, when activated to mechanically process lipoaspiratecontained inside a liposuction filter canister functionally-associatedwith the liposuction device, said mechanically processing reducing theaverage size of adipose tissue pieces in the lipoaspirate withoutsubstantially rupturing lipocytes therein.
 2. The liposuction device ofclaim 1, further comprising a liposuction vacuum module attachable to aliposuction filter canister functionally-associated with the liposuctiondevice through a vacuum port thereof, said liposuction vacuum moduleconfigured, when attached to a liposuction filter canister andactivated, to effect liposuction through said liposuction filtercanister and through a liposuction probe functionally associatedtherewith, thereby allowing trapping of harvested adipose tissue in afilter liner of the attached filter canister.
 3. The liposuction deviceof claim 2, configured to allow activation of said lipoaspirateprocessing unit to mechanically process the contents of a liposuctionfilter canister functionally associated with the liposuction devicewhile a liposuction filter canister is attached to said liposuctionvacuum module.
 4. The liposuction device of claim 2, said liposuctionvacuum module further configured to function as a fluid drainage moduleto remove liquids from a container of liposuction filter canisterfunctionally-associated with the liposuction device.
 5. The liposuctiondevice of claim 2, comprising a fluid drainage module different fromsaid liposuction vacuum module, said fluid drainage module attachable toa liposuction filter canister functionally-associated with theliposuction device through a drainage port thereof, said fluid drainagemodule configured, when attached to such a liposuction filter canisterand activated, to remove liquids from a container of the attachedliposuction filter canister.
 6. The liposuction device of claim 1,further comprising a liposuction probe having a distal end attachable toa liposuction cannula and a proximal end attachable to a liposuctionfilter canister functionally-associated with the liposuction devicethrough an aspirate inlet thereof, said liposuction probe configured todirect liposuction aspirate harvested via an attached liposuctioncannula into a container of an attached liposuction filter canister. 7.The liposuction device of claim 1, further comprising a washing moduleattachable to a liposuction filter canister functionally-associated withthe liposuction device through an access port thereof, configured to addan amount of liquid into a container of the attached liposuction filtercanister.
 8. The liposuction device of claim 7, further comprising acontroller configured to automatically process lipoaspirate contained ina liposuction filter canister that is functionally associated with theliposuction device, said automatic processing comprising activation ofsaid lipoaspirate processing unit, said fluid drainage module and saidwashing module in a desired order for a desired duration.
 9. Theliposuction device of claim 1, wherein said lipoaspirate processing unitcomprises a vortex-mixing unit, said vortex mixing unit configured, whenactivated, to produce and apply vortex-inducing motion to a liposuctionfilter canister functionally-associated with the liposuction device,said vortex-inducing motion effective to mechanically process saidlipoaspirate.
 10. The liposuction device of claim 1, wherein saidlipoaspirate processing unit comprises a vibration unit, said vibrationunit configured, when activated, to produce and apply vibrations tolipoaspirate contained inside a liposuction filter canisterfunctionally-associated with the liposuction device, said vibrationseffective to mechanically process said lipoaspirate.
 11. The liposuctiondevice of claim 1, wherein said lipoaspirate processing unit comprises:a mechanical mixing component configured to be positioned inside avolume enclosed by a filter liner of a liposuction filter canisterfunctionally-associated with the liposuction device; and a mixing motorconfigured to move lipoaspirate contained in said volume relative tosaid mechanical mixing component to mechanically-mix said lipoaspirate,said mechanical mixing effective to mechanically process saidlipoaspirate.
 12. A method of processing lipoaspirate, comprising: a.receiving a lipoaspirate harvested from a subject in a liposuctionfilter canister; b. subsequent to ‘a’, mechanically processing saidlipoaspirate inside said liposuction filter canister to mix saidlipoaspirate, said mechanical processing reducing the average size ofadipose tissue pieces in said lipoaspirate without substantiallyrupturing lipocytes therein; and c. subsequent to ‘b’, draining fromsaid liposuction filter canister fluid released from said lipoaspirateby said mechanical processing, thereby providing processed lipoaspiratecontained in said liposuction filter canister.
 13. The method of claim12, wherein said mechanical processing is selected from the groupconsisting of: vortex-mixing; vibrations; and mechanical mixing.
 14. Themethod of claim 12, wherein prior to and/or during said mechanicalprocessing, a volume of aqueous solution is added to said liposuctionfilter canister.
 15. The method of claim 12, further comprising:subsequent to said draining ‘c’, transferring said lipoaspirate to anautologous fat transfer (AFT) device.
 16. The method of claim 15,wherein said lipoaspirate in said liposuction filter canister is notwashed subsequent to said application of said mechanical processing ‘b’and prior to said transferring of said lipoaspirate to said AFT device.17. The method of claim 12, wherein said lipoaspirate in saidliposuction filter canister is not centrifuged subsequent to saidmechanical processing ‘b’ and prior to said transferring of saidlipoaspirate to said AFT device.
 18. The method of claim 12, furthercomprising: d. subsequent to ‘c’, applying additional mechanicalprocessing to said lipoaspirate contained in said liposuction filtercanister to mix said lipoaspirate, said additional mechanicallyprocessing reducing the average size of adipose tissue pieces in saidlipoaspirate without substantially rupturing lipocytes therein.
 19. Themethod of claim 18, further comprising: subsequent to said additionalapplication of said mechanical processing ‘d’, transferring saidlipoaspirate to an autologous fat transfer (AFT) device.
 20. The methodof claim 18, further comprising: e. subsequent to ‘d’, isolating fluidreleased from said lipoaspirate consequent to said additional mechanicalprocessing as an SVF fluid.